Browse Device Recalls
2,437 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,437 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 2,437 FDA device recalls in 2013.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 29, 2013 | R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: ... | One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and on... | Class II | Smith & Nephew Inc |
| May 29, 2013 | R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: ... | One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and on... | Class II | Smith & Nephew Inc |
| May 29, 2013 | Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTI... | The information regarding the FILM Mode calibration may have been considered difficult to interpr... | Class II | Siemens Medical Solutions USA, Inc |
| May 29, 2013 | ARTISTE with syngo RT Therapist version 4.3 Product Usage: The intended ... | The potential for a safety issue, for the image quality degradation, that is addressed by the Cus... | Class II | Siemens Medical Solutions USA, Inc |
| May 29, 2013 | Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM T... | A plate was inadvertently released to a sales consultant that was restricted for sale. | Class II | Synthes USA HQ, Inc. |
| May 28, 2013 | SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation th... | Customers are resetting the default values outside recommended factory settings. | Class II | Elekta, Inc. |
| May 28, 2013 | INFUSE(R) Bone Graft,LARGE II KIT, REF 7510800, Medtronic Sofamore Danek USA,... | Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu... | Class II | Medtronic Sofamor Danek USA Inc |
| May 28, 2013 | INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, ... | Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu... | Class II | Medtronic Sofamor Danek USA Inc |
| May 28, 2013 | STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA... | Under specific conditions, there is an unlikely potential to result in inadvertent laser firing o... | Class II | Abbott Medical Optics, Inc. |
| May 28, 2013 | NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog... | Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Ca... | Class II | Boston Scientific Corporation |
| May 28, 2013 | Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Materia... | Boston Scientific has discovered an inconsistent "Use By" expiration date on a single lot/batch o... | Class II | Boston Scientific Corporation |
| May 28, 2013 | NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Ca... | Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Ca... | Class II | Boston Scientific Corporation |
| May 28, 2013 | BARD PERIPHERAL VASCULAR VACCESS¿ PTA Balloon Dilatation Catheters, 8mm x 4cm... | Bard Peripheral Vascular (BPV) has confirmed that some product code/lot number combination of dev... | Class II | Bard Peripheral Vascular Inc |
| May 28, 2013 | Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss... | Carl Zeiss Microscopy, LLC is recalling the Polarizer D component used in All upright ZEISS micro... | Class II | Zeiss, Carl Inc |
| May 28, 2013 | VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System... | DJO, LLC has recently identified a product safety issue with the battery assembly for the VenaFlo... | Class II | DJO, LLC |
| May 28, 2013 | RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00... | Product labeled with incorrect expiration date. | Class III | Boston Scientific Corporation |
| May 28, 2013 | STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC ... | Under specific conditions, there is an unlikely potential to result in inadvertent laser firing o... | Class II | Abbott Medical Optics, Inc. |
| May 28, 2013 | StarDental Classique(TM) Diamond Dental Bur. Used for specific applicatio... | Recall was initiated because a manufacturing issue was found that prevented the diamond coating f... | Class II | Dental EZ Stardental Division |
| May 28, 2013 | INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek US... | Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu... | Class II | Medtronic Sofamor Danek USA Inc |
| May 28, 2013 | STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO M... | Under specific conditions, there is an unlikely potential to result in inadvertent laser firing o... | Class II | Abbott Medical Optics, Inc. |
| May 28, 2013 | All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2... | Customers are resetting the default values outside recommended factory settings. | Class II | Elekta, Inc. |
| May 28, 2013 | INFUSE(R) Bone Graft, LARGE KIT, REF 7510600, Medtronic Sofamore Danek USA, I... | Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu... | Class II | Medtronic Sofamor Danek USA Inc |
| May 28, 2013 | INFUSE(R) Bone Graft, SMALL KIT, REF 7510200AUS, Medtronic Sofamore Danek USA... | Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu... | Class II | Medtronic Sofamor Danek USA Inc |
| May 28, 2013 | INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek ... | Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu... | Class II | Medtronic Sofamor Danek USA Inc |
| May 28, 2013 | SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) ... | Beckman Coulter has confirmed customer reports of LACT Lot M210077 failing calibration with erro... | Class II | Beckman Coulter Inc. |
| May 28, 2013 | INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, I... | Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu... | Class II | Medtronic Sofamor Danek USA Inc |
| May 24, 2013 | MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalm... | Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory fun... | Class II | Nidek Inc |
| May 24, 2013 | AMICUS Exchange Kit; Product Usage: This kit is designed for use with th... | Fenwal has initiated a voluntary Urgent Product Recall for lot FA12C07070 of product code R4R2339... | Class II | Fenwal Inc |
| May 24, 2013 | S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an op... | The outer sleeve would not fit over the S-LIFT Inserter assembly because the hole at the top of t... | Class II | SpineFrontier, Inc. |
| May 24, 2013 | VIA Medical Collection Bag; The collection bag is an accessory waste bag use... | International Biomedical has received reports of interference between the collection bag and the ... | Class II | International Biomedical, Ltd. |
| May 24, 2013 | Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub... | Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Pro... | Class II | Fresenius Medical Care Holdings, Inc. |
| May 24, 2013 | GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 13071... | lack of sterility assurance | Class II | Gyrus Acmi, Incorporated |
| May 23, 2013 | Sovereign¿ Compact Phacoemulsification System, v 5.3, Part Number: CMP680300.... | Abbott Medical Optics Inc. (AMO) initiated this Urgent Notice of Medical Device Correction and Ad... | Class II | Abbott Medical Optics, Inc. |
| May 23, 2013 | Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, ... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO; si... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) Sterile, EO; singl... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Small Nonsterile 00... | This is a recall expansion from the 2010 recall which now includes seven additional lots that wer... | Class II | Zimmer, Inc. |
| May 23, 2013 | Swift Mobil shower chair, Swift Mobil 160 shower chair, and Swift Mobil Tilt ... | Etac is voluntarily conducting a field correction of the Etac Swift Mobil shower chair. If the Sw... | Class II | Etac Supply Center Ab |
| May 23, 2013 | Stryker Instruments0400-750-000 T4 Toga, Pullover, Regular Sterile, EO; sing... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO; singl... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Pinook Mini Massager Distributed by www.pinookusa.com. Used to strengthe... | Failure to submit a premarket submission and gain approval of a medical device. | Class II | Pinook-Usa |
| May 23, 2013 | ViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring Syste... | Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the... | Class II | Sotera Wireless, Inc. |
| May 23, 2013 | Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthe... | Failure to submit a premarket submission and gain approval of a medical device. | Class II | Pinook-Usa |
| May 23, 2013 | BC Hammock Mesh Sling (Junior), product number, 537005. Product Usage: T... | The product does not meet the firm's size standards, the product was produced in the incorrect size. | Class II | Prism Medical Services USA |
| May 23, 2013 | BC Hammock Mesh Sling (Medium), product number, 537005. Product Usage: U... | The product does not meet the firm's size standards, the product was produced in the incorrect size. | Class II | Prism Medical Services USA |
| May 23, 2013 | Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO;... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | BC Hammock Mesh Sling (Large), product number, 537030. Product Usage: The... | The product does not meet the firm's size standards, the product was produced in the incorrect size. | Class II | Prism Medical Services USA |
| May 23, 2013 | Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; ... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO; sin... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, Sterile, O; single ... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.